NGAL concentration in
specimen is positively correlated with the fluorescent density of
the microspheres, after the measure and calculation of
the quantitative
fluorescence immunoassay analyzer, then the analyzer would
calculate the concentration of NGAL according to the preset
calibration curve in the machine and display the result, detection
unit is ng/mL. C line should appear in any cases, which indicates
the reaction system is effective.
Applicable
instrument
Avid fluorescent
immunoanalyzer model: AI-IF **0
Manufacturer&
After-Sales Company: Shenzhen Aivd Biotechnology Co.,
LTD.
Address:C**1,Building
B5,China Merchants Guangming Science Park, #***9 Guanguang Road,
Guangming District, Shenzhen,Guangdong Province,
China
Tel: ************2
Fax:************5
Specimen collection
and preparation
1. Human
plasma/serum/whole blood samples can be used for this
test.
2. Specimen
collection:
Plasma/Serum:
The serum or plasma
should be separated by centrifugation immediately after the
collection of whole blood. Serum specimens must be collected in
standard or vacuum test tubes
with serum separating gel.
Specimens can be
stored at **8°C for 7 days after processing. The specimens frozen
at **0°C shouldn't be over 1 month. Multiple freeze-thaw
cycles shouldn't over 3
times.
Whole
Blood:
Collect blood specimen
into a collection tube containing EDTA or heparin or citric acid,
evenly mixed before use. Do not use hemolyzed blood for
testing.
Whole blood specimens
should be stored at **8°C for no more than 4 hours if not test
immediately.
3. Do not test
patients' samples with severe hemolysis, lipemia and jaundice, all
specimens should be treated as infectant.
4. Restore the
specimen to ****0°C before the detection, cryopreserved specimen
should be completely thawed, rewarmed and evenly mixed before
use.
Test
procedure
Read the complete
instruction before the test
1. Bring
the specimen and test
components to room temperature
(recommended temperature is about ****0 ºC ) to test. Open the
aluminum foil bag containing the test
kit after it get back to the room temperature. Keep the test kit in
a dry place to prevent spoilage from dampness. Before unpacking,
check whether
the aluminum foil bag is in good condition. Do not use it if it is
damaged. The test card should be used within 1 hour after
unpack.
2. Open the instrument
as its instruction and Insect the ID card to get the
curve.
3. Collect
**0μl of
sample(plasma/serum/whole blood), add to the sample diluent (mix
thoroughly for *0
sec with vortex mixer)
collect *0μl of
a sample mixture and load it
into the sample vertically and slowly.
4. Leave the
sample-loaded cartridge at room temperature (recommended
temperature is about ****0ºC) for *5 minutes. After time is over,
immediately insert it into the cartridge
holder of the instrument, press "Test" and read the
results.
5. Treat the tested
card as potential biological hazard.
6. Quality
Control:
1) As an effectiveness
indicator, C line should appear in any cases.
2) Aivd's internal
control materials or other approved applicable control materials
can be used to control the quality of the product, the test results
should be within the specified
quality control range.
Note: Perform the test
under the condition of temperature *0~*0ºC, humidity
*5~*5%.
Reference
range
Reference value:
*****0ng/mL; The reference value is verified by referring to
similar products on the market. Due to ethnic and regional
differences, each laboratory can
establish its own reference interval according to the actual
situation.
